The Patent Court recently rendered a decision clarifying one of the uncertainties in the Korean PTE legal system, by overturning the final rejection by Korean Intellectual Property Office (“KIPO”) of a patent term extension (“PTE”) application that was filed on the basis of the BELVIQ Tab., a psychotropic drug for treatment of obesity that was approved under the Narcotics Control Act, as opposed to the Pharmaceutical Affairs Act which governs most drug approvals in Korea.
The Korean Patent Act (“KPA”) provides that the specific types of inventions and approvals that can qualify for PTE are to be defined by its implementing regulations (the Enforcement Decree of the KPA), which KIPO is responsible for creating and administering. At present, the Enforcement Decree states that a patented invention covering a pharmaceutical product approved under the Pharmaceutical Affairs Act or an agrochemical product registered under the Pesticide Control Act is eligible for PTE. However, while the Pharmaceutical Affairs Act covers pharmaceutical product approvals in Korea in general, it provides that drugs that are potentially addictive or subject to abuse are to be regulated and approved under a separate law, the Narcotics Control Act.
Eisai (the “Plaintiff”) had applied for the PTE of five patents relating to the BELVIQ Tab. based on the approval of the drug under the Narcotics Control Act, rather than the Pharmaceutical Affairs Act. KIPO issued a final rejection of the PTE application on the ground that because the Narcotics Control Act was not expressly identified as a valid basis for PTE in the Enforcement Decree, no PTE could be granted for the patents at issue. This reasoning was confirmed at the first instance by the Intellectual Property Trial and Appeal Board (“IPTAB”). The Patent Court reversed the IPTAB’s decision and concluded that the PTE at issue was erroneously rejected, holding that the Enforcement Decree of the KPA failed to properly implement the full scope of the KPA concerning PTE eligibility, and therefore was an improper basis for the rejection in this case. KIPO did not appeal this decision, and accordingly the Patent Court decision became final and conclusive. Kim & Chang represented the Plaintiff in obtaining this favorable outcome.
In its decision, the Patent Court first determined that an approval under the Narcotics Control Act is substantially the same as an approval under the Pharmaceutical Affairs Act, given that the agency reviewing the approval, the entity obtaining the approval, the items to be reviewed for the approval, and the process and examination period for the approval are basically the same. The Patent Court then noted that although the KPA delegates to the Enforcement Decree the specific identification of inventions eligible for PTE, the KPA broadly defines such inventions as those involving approvals under other laws that require lengthy periods to conduct safety, validity or other testing before the approval can be issued. Thus, the Patent Court concluded that the KPA did not delegate to KIPO the authority to arbitrarily select only some “other laws” or types of approvals as eligible for PTE while excluding others that would also involve lengthy approval-related testing, and that as a result, the Enforcement Decree was defective and an improper basis for KIPO’s rejection in this case.
This decision is significant in that the Patent Court took the unusual step of construing in detail the intent of the relevant KPA provisions in this case and then determined that the Enforcement Decree was inconsistent with and improperly added limitations to the intended scope of the KPA provisions concerning PTE. Thus, despite arguably being literally within the scope of the KPA, the Enforcement Decree provision was deemed to be overly narrow in implementing its governing statute and, as a result, the KIPO rejection was overturned.
This decision also suggests that the Patent Court is beginning to take a more serious look at whether the Korean PTE system adequately protects patentees’ rights as currently implemented, with an eye to greater harmonization with other major PTE jurisdictions. It is expected that KIPO will amend the Enforcement Decree in the near term to clarify the proper basis for PTE.
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